Introducer Kit for Impella® 0052-3015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813502010244), received between Nov 8, 2017 and Apr 20, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Issue” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K122084); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2018Device Issue; Positioning Problem; Device Issue; Positioning Problem

  THE COMPLAINANT REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WAS TRANSFERRED TO THIS FACILITY FOR AN HRPCI PROCEDURE. IN PREPARATION OF PROVIDING IMPELLA CP SUPPORT THE PHYSICIAN DILATED THE LEFT ILIAC, BUT ENCOUNTERED AN ISSUE WHEN ADVANCING THE WIRE. THE PHYSICIAN THEN PLACED A BENTSON WIRE THROUGH THE 14FR DILATOR. THEN IMAGING REVEALED THAT THE DILATOR PERFORATED THE LEFT ILIAC. THE PHYSICIAN THEN CROSSED OVER FROM RIGHT ILIAC AND INFLATED A PERIPHERAL BALLOON TO HELP CONTROL BLEEDING. THE VASCULAR SURGEON THEN PERFORMED A CUT DOWN AND REPAIRED THE PERFORATION. A 7FR SHEATH WAS PLACED ABOVE THE PERFORATION, AND THE DOCTOR THEN SUCCESSFULLY PLACED AN IMPELLA CP INSIDE THE RIGHT ILIAC WITHOUT ISSUE. AS A RESULT OF THE PERFORATION THE PATIENT RECEIVED 6 UNITS OF PACKED RED BLOOD CELLS AND PLASMA. FOLLOWING THE PROCEDURE THE PATIENT WAS REPORTED TO BE STABLE AND DOING EXTREMELY WELL. FOLLOW-UP INFORMATION WAS RECEIVED FROM THE PHYSICIAN, WHO STATED THAT HE FEELS THE PROGLIDE PERCLOSE CREATED A NEW PATHWAY AND THE BENSON WIRE EXITED THE ARTERY AND THE DILATOR FOLLOWED RESULTING IN THE EVENT.

  Patient problems: Atrial Perforation; Blood Loss

  MAUDE report 7446542 ↗
• MalfunctionNov 8, 2017Kinked; Kinked

  AN (B)(6) FEMALE PATIENT WITH MULTIVESSEL DISEASE HAD AN IMPELLA 2.5 PLACED FOR SUPPORT FOR HRPCI ON (B)(6) 2017. THIS PATIENT HAS A HISTORY OF HAVING A PRIOR CORONARY ARTERY BYPASS GRAFT PROCEDURE. THE LEFT FEMORAL ARTERY WAS ASSESSED PRIOR TO INSERTION OF THE IMPELLA. THE 13 FR ABIOMED INTRODUCER WAS UNABLE TO BE INSERTED AND WAS FOUND TO BE KINKED. A 14 FR OSCOR INTRODUCER WAS ATTEMPTED TO BE INSERTED, HOWEVER THE INTRODUCER WAS UNABLE TO BE ADVANCED. A SECOND 13 FR ABIOMED INTRODUCER WAS ABLE TO BE INSERTED AND THE IMPELLA 2.5 WAS ADVANCED AND SUPPORT WAS INITIATED. THE PATIENT UNDERWENT A PRIMARY PROTECTED CORONARY INTERVENTION WHILE ON IMPELLA SUPPORT. AFTER THE PROCEDURE THE PATIENT WAS WEANED FROM THE IMPELLA 2.5 AND THE PUMP WAS EXPLANTED. TWO PERCLOSE SUTURES WERE USED FOR CLOSING THE INSERTION SITE. AT THE END OF THE CASE A FEMORAL RUNOFF ANGIOGRAM REVEALED VASCULATURE TIGHTNESS AND POOR FLOW TO THE LEFT FEMORAL ARTERY. THE CLINICAL TEAM DECIDED TO BALLOON AND PLACE A MEDTRONIC EVERFLEX STENT; AND FLOW WAS RESTORED. THERE WAS NO FURTHER ADVERSE EVENT TO THE PATIENT FOLLOWING THE STENT PLACEMENT.

  Patient problems: Tissue Damage

  MAUDE report 7011149 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122084. One submission often covers many models, so check the product and lot details in each record.

• Z-2678-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
• Z-2680-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
• Z-2679-2026 · Jun 10, 2026 · Open, Classified
  Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
• Z-1467-2021 · Feb 22, 2021 · Terminated
  AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheter